Senior Manager/Associate Director, Contract Manufacturing

Location
Brisbane, CA, United States
Posted
Mar 27, 2021
Ref
5049331002
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women's health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.

We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Manager, Contract Manufacturing. The position reports to the Vice President, Contract Manufacturing. The location of the position is in Brisbane, CA.

Summary Description

This Senor Manager, Contract Manufacturing is responsible for facilitating the selection and managing external packaging manufacturing sites to ensure quality, compliance and efficiency in meeting project needs and production requirements; collaborates with stakeholders and partners in defining matrix/process for selection of clinical and commercial manufacturing sites for Relugolix and other portfolio compounds, forecasting and managing development, launch and production schedules, establishing technical transfer strategies and tactics and project milestones.

The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Essential Duties and Responsibilities
  • Oversee and coordinate the overall evaluation and selection of external contract development & manufacturing organizations (CDMOs) for clinical and commercial needs.
  • Serves as the point of contact for Contract Development & Manufacturing Organizations (CDMOs), and act as a business relationship manager.
  • Actively manages contract manufacturers (CMOs) in assigned projects to coordinate technology transfer and development efforts per project milestones, timelines, and deliverables for projects, organizing project team meetings and steering committees and driving accountability.
  • Reviews and coordinate RFPs (request for proposals),
  • Places orders for custom manufactured materials, active pharmaceutical ingredients (APIs), bulk drug products and packaging components.
  • Coordinates release and stability tests for supplies, and shipping samples to various CROs as needed.
  • Monitors material shipments from global CMOs, resolves any related shipment issues
  • Investigates and resolves inventory / order discrepancies in a timely manner, follows up on invoicing and ensures on time payment as needed.
  • Monitors and verifies implementation of Myovant's controlled documents at CDMOs partner sites.
  • Coordinates meetings, participate in teleconferences and face to face meetings with CMOs/CROs, publishes agenda and meeting minutes. Leads the meetings.
  • Assist in review and revision of departmental SOPs in order to streamline and improve current practices.
  • Manages CMOs on a daily basis, responsible for all interactions with CMO's on the assigned projects.
  • Works with line manager and partner functions to develop processes/systems to effectively manage vendor selection and performance assessments.
  • Participates in solving issues of high complexity and generation of COGs.
  • Communicates issues to line manager and project team in a timely manner.
  • Develops specific manufacturing recommendations for coordination of production schedules, environmental concerns, and safety issues.
  • Coordinates production flow from Process Development to Manufacturing.
  • Supervises and monitors performance of Manufacturing Managers and Team Leaders. Coordinates production schedules based on sales and/or clinical requirements.
  • Responsible for driving continuous improvement in all operation processes
  • Perform other duties as assigned.

Core Competencies, Knowledge, and Skill Requirements
  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, honesty, integrity, and trust building
  • Behaviors in all dealings is essential and required
  • Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction
  • Daily demonstrates a positive, 'can do' and service-oriented attitude.
  • Strong oral and written communicator; detail-oriented with a commitment to accuracy
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks
  • Ability to multi-task and shift priorities quickly while working under tight deadlines.
  • Skilled in developing collaborative internal and external relationships

REQUIREMENTS

Education
  • Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline

Experience
  • 10+ years of progressive experience in the manufacturing environment and a BS or BA
  • 7+ years of packaging experience including launch experiences
  • 3-5 years of utilizing SAP to manage planning and inventory
  • Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs)
  • Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards


TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
  • Regularly required to operate standard office equipment
  • Ability to work on a computer for extended periods of time
  • Regularly required to sit for long periods of time, and occasionally stand and walk
  • Regularly required to use hands to operate computer and other office equipment
  • Close vision required for computer usage
  • Occasionally required to stoop, kneel, climb and lift up to 20 pounds

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

If you require any accommodations, please email careers@myovant.com.

Equal Employment Opportunity